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Monoclonal Antibodies
Durvalumab + Chemotherapy for Mesothelioma (DREAM3R Trial)
Phase 3
Waitlist Available
Research Sponsored by PrECOG, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults (18 years or over) with a histological diagnosis of epithelioid pleural mesothelioma that is not amenable to curative surgical resection. Histological diagnosis requires tumour tissue from an open biopsy, or a core biopsy with a needle of 19 gauge or wider.
Measurable disease as per modified RECIST 1.1 (mRECIST 1.1) criteria for assessment of response in pleural mesothelioma, without prior radiotherapy to these sites.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days after last dose of immunotherapy or 30 days after last dose of chemotherapy, whichever is longer.
Awards & highlights
DREAM3R Trial Summary
This trial will test a new treatment, durvalumab, for patients with malignant pleural mesothelioma who cannot have surgery to remove their tumor. Two-thirds of participants will receive durvalumab in addition to standard chemotherapy. Researchers hope that adding durvalumab to chemotherapy will improve patients' overall survival.
Who is the study for?
Adults over 18 with epithelioid pleural mesothelioma that can't be removed by surgery. They should have a good performance status, weigh more than 30 kg, and have acceptable blood test results. Women must not be pregnant and use contraception; men also need to follow certain contraceptive guidelines.Check my eligibility
What is being tested?
The trial is testing if adding durvalumab (an immunotherapy drug) to standard chemotherapy improves survival in patients with advanced pleural mesothelioma compared to standard chemotherapy alone or combined with other immunotherapies like ipilimumab and nivolumab.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects such as inflammation of organs, fatigue, infusion reactions similar to allergic responses, and increased risk of infections. Chemotherapy can lead to nausea, hair loss, fatigue, and an increased risk of infection.
DREAM3R Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult diagnosed with a type of cancer called epithelioid pleural mesothelioma that cannot be removed by surgery.
Select...
My cancer can be measured and hasn't been treated with radiation at these spots.
Select...
My tumor tissue is available for PD-L1 and other tests.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My body weight is over 30 kg.
Select...
I am post-menopausal or have a negative pregnancy test if pre-menopausal.
DREAM3R Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days after last dose of immunotherapy or 30 days after last dose of chemotherapy, whichever is longer.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days after last dose of immunotherapy or 30 days after last dose of chemotherapy, whichever is longer.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effects on Overall Survival
Secondary outcome measures
Classify and grade participants adverse events as assessed by CTCAE V5.0
Health Care Usage Costs: Hospitalization
Health Care Usage Costs: Medications
+6 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
DREAM3R Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm: Durvalumab + Chemotherapy, then Durvalumab MaintenanceExperimental Treatment1 Intervention
Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
Group II: Control Arm: Chemotherapy, then ObservationActive Control1 Intervention
Standard Chemotherapy for 4 to 6 cycles, followed by Observation
Group III: Control Arm: Ipilimumab and NivolumabActive Control1 Intervention
Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
Thoracic Oncology Group Australasia (TOGA)UNKNOWN
University of SydneyOTHER
190 Previous Clinical Trials
214,518 Total Patients Enrolled
PrECOG, LLC.Lead Sponsor
17 Previous Clinical Trials
7,244 Total Patients Enrolled
1 Trials studying Mesothelioma
55 Patients Enrolled for Mesothelioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis was confirmed with a fine needle biopsy.I have hearing loss or nerve issues that prevent me from taking certain medications.I do not have active brain cancer symptoms or uncontrolled brain metastases.I have or had an autoimmune or inflammatory condition.I have not had major surgery in the last 28 days.I am an adult diagnosed with a type of cancer called epithelioid pleural mesothelioma that cannot be removed by surgery.I have received chemotherapy or immunotherapy for my cancer.I haven't had a live vaccine in the last 30 days.I have previously been treated with drugs that target the immune system.My cancer can be measured and hasn't been treated with radiation at these spots.My tumor tissue is available for PD-L1 and other tests.I am fully active or restricted in physically strenuous activity but can do light work.I have a history of immune system issues, organ transplant, lung inflammation, or active TB.You have hepatitis B, hepatitis C, or HIV.My cancer is not the common type; it's either biphasic or sarcomatoid.My heart's electrical activity (QTcF) is normal or I don't have a family history of long QT syndrome.I do not have any serious ongoing illnesses that are not under control.I am not taking any medications that could interfere with the study drug.My body weight is over 30 kg.Your recent blood tests need to show certain values within a specific range.I do not have any other cancer that needs treatment.I am post-menopausal or have a negative pregnancy test if pre-menopausal.I am using or will use effective birth control during and after the study for at least 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm: Durvalumab + Chemotherapy, then Durvalumab Maintenance
- Group 2: Control Arm: Chemotherapy, then Observation
- Group 3: Control Arm: Ipilimumab and Nivolumab
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other ongoing or completed research projects that use Durvalumab?
"As of right now, there are 1470 active trials studying Durvalumab with 430 in Phase 3. The great majority of these studies are based in Shanghai, but there are 74679 locations worldwide where research is being conducted."
Answered by AI
Is Durvalumab likely to cause any serious harm to patients?
"There is a fair amount of clinical data to support the safety of Durvalumab, so it received a score of 3."
Answered by AI
What are the primary conditions thatDurvalumab is meant to address?
"Durvalumab is the go-to medication for initial treatment, but it has also shown effectiveness in treating other conditions like advanced thymoma, advanced testicular cancer, and carcinoma, neuroendocrine."
Answered by AI
Why did researchers design this clinical trial?
"According to the trial sponsor, AstraZeneca, the primary outcome of this study will be Overall Survival, which will be measured over a 24-month period. In addition to the primary outcome, this study will also be measuring secondary outcomes including Health Care Usage Costs: Hospitalization, Health Care Usage Costs: Medications, and Health-Related QOL: LC29."
Answered by AI
What is the largest number of people who have taken part in this research project?
"That is correct. The clinicaltrials.gov website does have this trial listed as currently recruiting. It was first posted on February 18th, 2021 and was updated as recently as October 24th, 2022. They are looking for a total of 480 people to participate at 25 different sites."
Answered by AI
Is this research being conducted widely throughout the United States?
"The University of Chicago, NorthShore University Health System/Kellogg Cancer Center, Emory University, and 25 other medical facilities are running this clinical trial."
Answered by AI
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